Medicine
Spironolactone 100 mg tablet
Spironolactone 100 mg tablet is a generic prescription medicine for oral use, made by 27 labelers, with its source record on the US FDA register. It is available on request for export supply from India to licensed hospitals, importers and physicians.
Availability
Export supply from India to licensed buyers
Typical lead time
On request
Counted from payment and complete documents
Shipping
Ambient
Store below 77°F (25°C).
Key facts
- Active ingredient (INN)
- Spironolactone
- Brand
- Sold under the generic name
- Strength
- 100 mg
- Dosage form
- Tablet
- Route
- Oral
- Packs
- 100 tablets, 500 tablets, 30 tablets and 128 more
- Manufacturers
- Zydus LifesciencesIndiaCamber PharmaceuticalsIndiaJubilant Cadista PharmaceuticalsIndiaSun Pharmaceutical IndustriesIndiaAccord HealthcareIndiaAurobindo PharmaIndiaAmneal PharmaceuticalsAmneal Pharmaceuticals of New York27 labelers on the register
- Origin register
- US FDA, United States
- Storage
- Store below 77°F (25°C).
- Cold chain
- Not required on record
- Prescription status
- Prescription only
- Controlled substance
- Not recorded as controlled
- ATC code
- C03DA01 Spironolactone
- HS code (indicative)
- 3004.90Indicative only. Your customs broker confirms the final tariff code.
- Marketing category
- marketed
- Marketed since
- 23 July 1986
- Identifiers
- RxCUI 198222, 198223, 313096DailyMed set ID db22e9e5-2d88-4712-a809-c00881edb447, c0efa529-2870-4260-b604-2f30e2cbb87b, 08738ad4-1607-4d55-af71-6790477353bd +37NDC 76420-927, 43063-835, 50090-6539 +37Application ANDA040750, ANDA203512, ANDA089424 +7
Record updated 12 November 2026
Documents available
Documents that can be provided with this medicine. Your regulator may ask for more, and the quote lists the full set.
No document list is recorded for this medicine yet. Tell us which documents your regulator needs (for example a CoA, COPP or GMP certificate) when you request a quote.
Packs
A sample of 40 packs from 27 labelers. The register lists 131 packs for this generic presentation, and we confirm the exact pack on the quote.
| Pack | Code | Labeler | Marketed since |
|---|---|---|---|
| 100 tablet, film coated in 1 bottle | 59746-218-01 | Jubilant Cadista PharmacuticalsIndia | 4 April 2017 |
| 500 tablet, film coated in 1 bottle | 59746-218-05 | Jubilant Cadista PharmacuticalsIndia | 4 April 2017 |
| 100 tablet, film coated in 1 bottle | 59746-218-06 | Jubilant Cadista PharmacuticalsIndia | 4 April 2017 |
| 500 tablet, film coated in 1 bottle | 59746-218-09 | Jubilant Cadista PharmacuticalsIndia | 4 April 2017 |
| 100 tablet, film coated in 1 bottle | 68382-662-01 | Zydus LifesciencesIndia | 15 August 2018 |
| 500 tablet, film coated in 1 bottle | 68382-662-05 | Zydus LifesciencesIndia | 15 August 2018 |
| 30 tablet, film coated in 1 bottle | 68382-662-06 | Zydus LifesciencesIndia | 15 August 2018 |
| 1000 tablet, film coated in 1 bottle | 68382-662-10 | Zydus LifesciencesIndia | 15 August 2018 |
| 90 tablet, film coated in 1 bottle | 68382-662-16 | Zydus LifesciencesIndia | 15 August 2018 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 68382-662-30 | Zydus LifesciencesIndia | 15 August 2018 |
| 1000 tablet, film coated in 1 bottle | 70771-1029-0 | Zydus LifesciencesIndia | 15 August 2018 |
| 100 tablet, film coated in 1 bottle | 70771-1029-1 | Zydus LifesciencesIndia | 15 August 2018 |
| 30 tablet, film coated in 1 bottle | 70771-1029-3 | Zydus LifesciencesIndia | 15 August 2018 |
| 10 blister pack in 1 carton / 10 tablet, film coated in 1 blister pack | 70771-1029-4 | Zydus LifesciencesIndia | 15 August 2018 |
| 500 tablet, film coated in 1 bottle | 70771-1029-5 | Zydus LifesciencesIndia | 15 August 2018 |
| 90 tablet, film coated in 1 bottle | 70771-1029-9 | Zydus LifesciencesIndia | 15 August 2018 |
| 100 tablet, film coated in 1 bottle | 16729-227-01 | Accord HealthcareIndia | 2 June 2017 |
| 500 tablet, film coated in 1 bottle | 16729-227-16 | Accord HealthcareIndia | 2 June 2017 |
| 100 tablet in 1 bottle | 59651-428-01 | Aurobindo PharmaIndia | 13 December 2019 |
| 500 tablet in 1 bottle | 59651-428-05 | Aurobindo PharmaIndia | 24 August 2023 |
| 100 tablet, film coated in 1 bottle | 31722-096-01 | Camber PharmaceuticalsIndia | 25 July 2025 |
| 500 tablet, film coated in 1 bottle | 31722-096-05 | Camber PharmaceuticalsIndia | 25 July 2025 |
| 1000 tablet, film coated in 1 bottle | 31722-096-10 | Camber PharmaceuticalsIndia | 25 July 2025 |
| 30 tablet, film coated in 1 bottle | 31722-096-30 | Camber PharmaceuticalsIndia | 25 July 2025 |
| 50 tablet, film coated in 1 bottle, plastic | 53489-329-02 | Sun Pharmaceutical IndustriesIndia | 23 July 1986 |
| 250 tablet, film coated in 1 bottle, plastic | 53489-329-03 | Sun Pharmaceutical IndustriesIndia | 23 July 1986 |
| 500 tablet, film coated in 1 bottle, plastic | 53489-329-05 | Sun Pharmaceutical IndustriesIndia | 23 July 1986 |
| 1000 tablet, film coated in 1 bottle, plastic | 53489-329-10 | Sun Pharmaceutical IndustriesIndia | 23 July 1986 |
| 30 tablet in 1 bottle | 65162-515-03 | Amneal Pharmaceuticals | 2 August 2010 |
| 60 tablet in 1 bottle | 65162-515-06 | Amneal Pharmaceuticals | 2 August 2010 |
| 90 tablet in 1 bottle | 65162-515-09 | Amneal Pharmaceuticals | 2 August 2010 |
| 100 tablet in 1 bottle | 65162-515-10 | Amneal Pharmaceuticals | 2 August 2010 |
| 1000 tablet in 1 bottle | 65162-515-11 | Amneal Pharmaceuticals | 2 August 2010 |
| 500 tablet in 1 bottle | 65162-515-50 | Amneal Pharmaceuticals | 2 August 2010 |
| 100 tablet in 1 blister pack | 65162-515-60 | Amneal Pharmaceuticals | 2 August 2010 |
| 100 tablet in 1 bottle | 53746-515-01 | Amneal Pharmaceuticals of New York | 2 August 2010 |
| 500 tablet in 1 bottle | 53746-515-05 | Amneal Pharmaceuticals of New York | 2 August 2010 |
| 1000 tablet in 1 bottle | 53746-515-10 | Amneal Pharmaceuticals of New York | 2 August 2010 |
| 30 tablet in 1 bottle | 53746-515-30 | Amneal Pharmaceuticals of New York | 2 August 2010 |
| 60 tablet in 1 bottle | 53746-515-60 | Amneal Pharmaceuticals of New York | 2 August 2010 |
Status by register
Where this medicine is registered, from the source record and the regulator data we hold. Ask us about a country that is not listed.
Import route
Pick the destination country to see the legal import route, who applies and typical timelines, from our import guide for that country.
Import guides are available for 25 countries. Pick one to see its route summary.
BrazilColombiaEgyptEthiopiaGhanaIraqKazakhstanKenyaAll import guides
Alternatives
Other makers and brands of Spironolactone 100 mg tablet.
Other strengths and forms of Spironolactone
Clinical summary
Spironolactone is an aldosterone antagonist indicated for the treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival, manage edema, and to reduce the need for hospitalization for heart failure. MedsAcross supplies Spironolactone for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Read about SpironolactoneFor healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
Data sources
- DailyMed label record · Checked 12 November 2026
- Aldactone prescribing information (Pfizer Laboratories) · U.S. National Library of Medicine, DailyMed
- Qaialdo: European public assessment report (EPAR) · European Medicines Agency
Need Spironolactone 100 mg tablet for your hospital or patient?
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